{\rtf1\adeflang1025\ansi\ansicpg1252\uc1\adeff0\deff0\stshfdbch0\stshfloch0\stshfhich0\stshfbi0\deflang4105\deflangfe4105\themelang4105\themelangfe0\themelangcs0{\fonttbl{\f0\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}{\f1\fbidi \fswiss\fcharset0\fprq2{\*\panose 020b0604020202020204}Arial;}
{\f3\fbidi \froman\fcharset2\fprq2{\*\panose 05050102010706020507}Symbol;}{\f34\fbidi \froman\fcharset0\fprq2{\*\panose 02040503050406030204}Cambria Math;}{\f40\fbidi \fswiss\fcharset0\fprq2{\*\panose 020b0604030504040204}Verdana;}
{\f43\fbidi \fswiss\fcharset0\fprq2{\*\panose 020b0606020202030204}Arial Narrow;}{\f44\fbidi \fswiss\fcharset128\fprq2{\*\panose 020b0600070205080204}MS PGothic;}{\f45\fbidi \fswiss\fcharset128\fprq2 @MS PGothic;}
{\flomajor\f31500\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}{\fdbmajor\f31501\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}
{\fhimajor\f31502\fbidi \fswiss\fcharset0\fprq2{\*\panose 020f0302020204030204}Calibri Light;}{\fbimajor\f31503\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}
{\flominor\f31504\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}{\fdbminor\f31505\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}
{\fhiminor\f31506\fbidi \fswiss\fcharset0\fprq2{\*\panose 020f0502020204030204}Calibri;}{\fbiminor\f31507\fbidi \froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}{\f46\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}
{\f47\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}{\f49\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}{\f50\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}{\f51\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}
{\f52\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}{\f53\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}{\f54\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}{\f56\fbidi \fswiss\fcharset238\fprq2 Arial CE;}
{\f57\fbidi \fswiss\fcharset204\fprq2 Arial Cyr;}{\f59\fbidi \fswiss\fcharset161\fprq2 Arial Greek;}{\f60\fbidi \fswiss\fcharset162\fprq2 Arial Tur;}{\f61\fbidi \fswiss\fcharset177\fprq2 Arial (Hebrew);}
{\f62\fbidi \fswiss\fcharset178\fprq2 Arial (Arabic);}{\f63\fbidi \fswiss\fcharset186\fprq2 Arial Baltic;}{\f64\fbidi \fswiss\fcharset163\fprq2 Arial (Vietnamese);}{\f446\fbidi \fswiss\fcharset238\fprq2 Verdana CE;}
{\f447\fbidi \fswiss\fcharset204\fprq2 Verdana Cyr;}{\f449\fbidi \fswiss\fcharset161\fprq2 Verdana Greek;}{\f450\fbidi \fswiss\fcharset162\fprq2 Verdana Tur;}{\f453\fbidi \fswiss\fcharset186\fprq2 Verdana Baltic;}
{\f454\fbidi \fswiss\fcharset163\fprq2 Verdana (Vietnamese);}{\f476\fbidi \fswiss\fcharset238\fprq2 Arial Narrow CE;}{\f477\fbidi \fswiss\fcharset204\fprq2 Arial Narrow Cyr;}{\f479\fbidi \fswiss\fcharset161\fprq2 Arial Narrow Greek;}
{\f480\fbidi \fswiss\fcharset162\fprq2 Arial Narrow Tur;}{\f483\fbidi \fswiss\fcharset186\fprq2 Arial Narrow Baltic;}{\f488\fbidi \fswiss\fcharset0\fprq2 MS PGothic Western;}{\f486\fbidi \fswiss\fcharset238\fprq2 MS PGothic CE;}
{\f487\fbidi \fswiss\fcharset204\fprq2 MS PGothic Cyr;}{\f489\fbidi \fswiss\fcharset161\fprq2 MS PGothic Greek;}{\f490\fbidi \fswiss\fcharset162\fprq2 MS PGothic Tur;}{\f493\fbidi \fswiss\fcharset186\fprq2 MS PGothic Baltic;}
{\f498\fbidi \fswiss\fcharset0\fprq2 @MS PGothic Western;}{\f496\fbidi \fswiss\fcharset238\fprq2 @MS PGothic CE;}{\f497\fbidi \fswiss\fcharset204\fprq2 @MS PGothic Cyr;}{\f499\fbidi \fswiss\fcharset161\fprq2 @MS PGothic Greek;}
{\f500\fbidi \fswiss\fcharset162\fprq2 @MS PGothic Tur;}{\f503\fbidi \fswiss\fcharset186\fprq2 @MS PGothic Baltic;}{\flomajor\f31508\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}
{\flomajor\f31509\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}{\flomajor\f31511\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}{\flomajor\f31512\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}
{\flomajor\f31513\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}{\flomajor\f31514\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}{\flomajor\f31515\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}
{\flomajor\f31516\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}{\fdbmajor\f31518\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}{\fdbmajor\f31519\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}
{\fdbmajor\f31521\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}{\fdbmajor\f31522\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}{\fdbmajor\f31523\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}
{\fdbmajor\f31524\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}{\fdbmajor\f31525\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}{\fdbmajor\f31526\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}
{\fhimajor\f31528\fbidi \fswiss\fcharset238\fprq2 Calibri Light CE;}{\fhimajor\f31529\fbidi \fswiss\fcharset204\fprq2 Calibri Light Cyr;}{\fhimajor\f31531\fbidi \fswiss\fcharset161\fprq2 Calibri Light Greek;}
{\fhimajor\f31532\fbidi \fswiss\fcharset162\fprq2 Calibri Light Tur;}{\fhimajor\f31533\fbidi \fswiss\fcharset177\fprq2 Calibri Light (Hebrew);}{\fhimajor\f31534\fbidi \fswiss\fcharset178\fprq2 Calibri Light (Arabic);}
{\fhimajor\f31535\fbidi \fswiss\fcharset186\fprq2 Calibri Light Baltic;}{\fhimajor\f31536\fbidi \fswiss\fcharset163\fprq2 Calibri Light (Vietnamese);}{\fbimajor\f31538\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}
{\fbimajor\f31539\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}{\fbimajor\f31541\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}{\fbimajor\f31542\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}
{\fbimajor\f31543\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}{\fbimajor\f31544\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}{\fbimajor\f31545\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}
{\fbimajor\f31546\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}{\flominor\f31548\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}{\flominor\f31549\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}
{\flominor\f31551\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}{\flominor\f31552\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}{\flominor\f31553\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}
{\flominor\f31554\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}{\flominor\f31555\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}{\flominor\f31556\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}
{\fdbminor\f31558\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}{\fdbminor\f31559\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}{\fdbminor\f31561\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}
{\fdbminor\f31562\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}{\fdbminor\f31563\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}{\fdbminor\f31564\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}
{\fdbminor\f31565\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}{\fdbminor\f31566\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}{\fhiminor\f31568\fbidi \fswiss\fcharset238\fprq2 Calibri CE;}
{\fhiminor\f31569\fbidi \fswiss\fcharset204\fprq2 Calibri Cyr;}{\fhiminor\f31571\fbidi \fswiss\fcharset161\fprq2 Calibri Greek;}{\fhiminor\f31572\fbidi \fswiss\fcharset162\fprq2 Calibri Tur;}
{\fhiminor\f31573\fbidi \fswiss\fcharset177\fprq2 Calibri (Hebrew);}{\fhiminor\f31574\fbidi \fswiss\fcharset178\fprq2 Calibri (Arabic);}{\fhiminor\f31575\fbidi \fswiss\fcharset186\fprq2 Calibri Baltic;}
{\fhiminor\f31576\fbidi \fswiss\fcharset163\fprq2 Calibri (Vietnamese);}{\fbiminor\f31578\fbidi \froman\fcharset238\fprq2 Times New Roman CE;}{\fbiminor\f31579\fbidi \froman\fcharset204\fprq2 Times New Roman Cyr;}
{\fbiminor\f31581\fbidi \froman\fcharset161\fprq2 Times New Roman Greek;}{\fbiminor\f31582\fbidi \froman\fcharset162\fprq2 Times New Roman Tur;}{\fbiminor\f31583\fbidi \froman\fcharset177\fprq2 Times New Roman (Hebrew);}
{\fbiminor\f31584\fbidi \froman\fcharset178\fprq2 Times New Roman (Arabic);}{\fbiminor\f31585\fbidi \froman\fcharset186\fprq2 Times New Roman Baltic;}{\fbiminor\f31586\fbidi \froman\fcharset163\fprq2 Times New Roman (Vietnamese);}}
{\colortbl;\red0\green0\blue0;\red0\green0\blue255;\red0\green255\blue255;\red0\green255\blue0;\red255\green0\blue255;\red255\green0\blue0;\red255\green255\blue0;\red255\green255\blue255;\red0\green0\blue128;\red0\green128\blue128;\red0\green128\blue0;
\red128\green0\blue128;\red128\green0\blue0;\red128\green128\blue0;\red128\green128\blue128;\red192\green192\blue192;\red0\green0\blue0;\red0\green0\blue0;\red255\green255\blue255;}{\*\defchp }{\*\defpap 
\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 }\noqfpromote {\stylesheet{\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \snext0 \sqformat \spriority0 Normal;}{\s1\ql \li0\ri0\sb240\sa60\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \ab\af1\afs32\alang1025 
\ltrch\fcs0 \b\f1\fs32\lang2057\langfe1033\kerning32\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sqformat \spriority0 heading 1;}{
\s2\ql \li0\ri0\sb240\sa60\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \ab\ai\af1\afs28\alang1025 \ltrch\fcs0 \b\i\f1\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
\sbasedon0 \snext0 \sqformat \spriority0 heading 2;}{\s3\ql \li0\ri0\sb240\sa60\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \ab\af1\afs26\alang1025 \ltrch\fcs0 
\b\f1\fs26\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sqformat \spriority0 heading 3;}{\s4\ql \li0\ri0\sb120\sa240\keepn\widctlpar\jclisttab\tx360\tx1152\wrapdefault{\*\pn \pnlvlbody\ilvl3\ls152\pnrnot0\pndec }
\aspalpha\aspnum\faauto\ls152\ilvl3\outlinelevel3\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 \b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon3 \snext0 \sqformat \spriority0 heading 4;}{
\s5\ql \li0\ri0\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel4\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
\sbasedon0 \snext0 \sqformat \spriority0 heading 5;}{\s6\ql \li0\ri0\sb240\sa60\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel5\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sqformat \spriority0 heading 6;}{\*\cs10 \additive \ssemihidden \spriority0 Default Paragraph Font;}{\*
\ts11\tsrowd\trftsWidthB3\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tblind0\tblindtype3\tsvertalt\tsbrdrt\tsbrdrl\tsbrdrb\tsbrdrr\tsbrdrdgl\tsbrdrdgr\tsbrdrh\tsbrdrv 
\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 \fs20\lang4105\langfe4105\cgrid\langnp4105\langfenp4105 \snext11 \ssemihidden \sunhideused Normal Table;}{
\s15\ql \li960\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin960\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 
toc 5;}{\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
\sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 1;}{\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 2;}{\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 3;}{\s19\ql \li720\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 4;}{
\s20\ql \li1200\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1200\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 
toc 6;}{\s21\ql \li1440\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
\sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 7;}{\s22\ql \li1680\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1680\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 8;}{\s23\ql \li1920\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1920\itap0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \sautoupd \ssemihidden \spriority0 toc 9;}{\*\cs24 \additive \rtlch\fcs1 \af0 \ltrch\fcs0 \ul\cf2 \sbasedon10 \ssemihidden \spriority0 Hyperlink;}{
\s25\qc \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext25 \sqformat \spriority0 Title;}{
\s26\ql \li-709\ri-766\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin-766\lin-709\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext26 \ssemihidden \spriority0 
Block Text;}{\s27\ql \li-709\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin-709\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
\sbasedon0 \snext27 \ssemihidden \spriority0 Body Text Indent;}{\s28\ql \li-709\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin-709\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext28 \ssemihidden \spriority0 Body Text Indent 2;}{\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \spriority0 Hidden Text;}{\s30\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext30 \spriority0 list:ssp;}{\s31\ql \li0\ri0\sa240\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon32 \snext31 \spriority0 caption:tabtext;}{\s32\ql \li1440\ri0\sa240\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon33 \snext36 \spriority0 caption:tabsumm;}{
\s33\ql \fi-1440\li1440\ri0\sa240\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon34 \snext36 \spriority0 
caption:table;}{\s34\ql \fi-1440\li1440\ri0\sa240\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
\sbasedon35 \snext0 \spriority0 caption:figure;}{\s35\ql \fi-1440\li1440\ri0\sa240\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext0 \spriority0 caption:equation;}{\s36\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 
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\ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 \sbasedon0 \snext37 \ssemihidden \spriority0 Body Text;}{\s38\ql \fi-360\li360\ri0\widctlpar\tx360\wrapdefault{\*\pn \pnlvlbody\ilvl11\ls2047\pnrnot0
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\psz9\pgnrestart\linex0\headery544\footery533\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
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\ltrch\fcs0 \insrsid10500643 MEDICINES CONTROL AGENCY
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\b\insrsid10500643 Clinical Trials Unit
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\ltrch\fcs0 \insrsid10500643 
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\par ILLUSTRATIVE GUIDANCE FOR APPLICATIONS TO THE COMPETENT AUTHORITY TO COMMENCE A CLINICAL TRIAL IN EARLY PHASE OF DEVELOPMENT ENTR/6418/01
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\insrsid10500643 
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\par \page ANNEX 5
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\ltrch\fcs0 \insrsid10500643 ILLUSTRATIVE GUIDANCE FOR APPLICATIONS TO THE COMPETENT AUTHORITY TO COMMENCE A CLINICAL TRIAL IN EARLY PHASE OF DEVELOPMENT ENTR/6418/01
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\ltrch\fcs0 \insrsid10500643 Introduction
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\insrsid10500643 This guidance presents a mock application for a fictitious produ
ct. The information presented illustrates the quantity and level of detail expected where it is available. If information for a section is not available this should be clearly stated. In the case of products where certain types of data cannot be provided 
this should be justified briefly. It should be noted assessors/reviewers do not need details of methods for standard tests and prefer data presented as tables with a brief discussion of the results and any conclusion. 
\par 
\par The guidance presents illustrative da
ta relating to the pharmaceutical, non-clinical and clinical aspects of an investigational product. It is assumed that applicants will derive this information from tests carried out to the current standards of GMP, GLP and GCP and that they will have foll
o
wed regulatory guidance on conducting the tests, if available. The application should draw attention to any deviations from these standards and provide a justification. Finally although this illustrative guidance does not provide information under all hea
d
ings, it is important to note that all available information relating to the investigational product should be provided at the time of the application. Where possible information should be presented using the headings listed in Attachments 1 to 3 of the g
uideline.
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\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615312}CHEMICAL PHARMACEUTICAL AND BIOLOGICAL DATA{\*\bkmkend _Toc534615312}
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\ltrch\fcs0 \insrsid10500643 Introduction
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 This Clinical Trial Application presents information relating to AB1234 Capsules containing 1mg, 2.5mg or 5mg of AB1234 (as the sodium salt).  AB1234 is a proton pump inhibitor and is being
 developed for the treatment of gastro-oesophageal reflux disease.  }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615313}2.1.S\tab DRUG SUBSTANCE{\*\bkmkend _Toc534615313}
\par {\*\bkmkstart _Toc534615316}2.1.S.1\tab General Information{\*\bkmkend _Toc534615316}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615317}2.1.S.1.1\tab Nomenclature{\*\bkmkend _Toc534615317}
\par \ltrrow}\trowd \ltrrow\ts11\trgaph107\trleft-90\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind17\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4086\clshdrawnil 
\cellx3996\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4644\clshdrawnil \cellx8640\pard\plain \ltrpar
\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
Chemical Name (IUPAC)\cell }\pard\plain \ltrpar\s29\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 The chemical name would be provided\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \v\cf6\insrsid10500643 
\trowd \ltrrow\ts11\trgaph107\trleft-90\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind17\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4086\clshdrawnil \cellx3996
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4644\clshdrawnil \cellx8640\row \ltrrow}\pard\plain \ltrpar
\s30\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
Code Name\cell }\pard\plain \ltrpar\s31\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \f0\insrsid10500643 AB1234 sodium salt\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \v\cf6\insrsid10500643 \trowd \ltrrow\ts11\trgaph107\trleft-90\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind17\tblindtype3 \clvertalt\clbrdrt\brdrtbl 
\clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4086\clshdrawnil \cellx3996\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4644\clshdrawnil \cellx8640\row \ltrrow
}\pard\plain \ltrpar\s30\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Other names\cell }\pard\plain \ltrpar\s31\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f0\insrsid10500643 \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \v\cf6\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph107\trleft-90\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind17\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4086\clshdrawnil \cellx3996\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4644\clshdrawnil \cellx8640\row }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615318}2.1.S.1.2\tab Structure}{\rtlch\fcs1 \af0 \ltrch\fcs0 \v\insrsid10500643 {\*\bkmkend _Toc534615318}
\par \ltrrow}\trowd \lastrow \ltrrow\ts11\trgaph107\trleft-107\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4077\clshdrawnil \cellx3970\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4394\clshdrawnil \cellx8364\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
Structural Formula \cell }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 The chemical structure would be provided\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph107\trleft-107\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4077\clshdrawnil \cellx3970\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4394\clshdrawnil 
\cellx8364\row }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615319}2.1.S.1.3\tab General Properties{\*\bkmkend _Toc534615319}
\par \ltrrow}\trowd \ltrrow\ts11\trgaph107\trleft-108\trftsWidth1\trftsWidthA3\trwWidthA50\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4404\clshdrawnil \cellx8364\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Molecular Formula
\cell }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 The molecular formula would be presented}{\rtlch\fcs1 \af0 \ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 .\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph107\trleft-108\trftsWidth1\trftsWidthA3\trwWidthA50\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4404\clshdrawnil \cellx8364\row \ltrrow}\pard\plain \ltrpar\s30\ql \li0\ri0\sa120\widctlpar\intbl
\tx567\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Molecular Weight\cell 
}\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 The molecular weight would be presented}{\rtlch\fcs1 \af0 \ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 .\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph107\trleft-108\trftsWidth1\trftsWidthA3\trwWidthA50\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4404\clshdrawnil \cellx8364\row \ltrrow}\trowd \ltrrow
\ts11\trgaph107\trrh866\trleft-108\trftsWidth1\trftsWidthA3\trwWidthA50\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil 
\cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4404\clshdrawnil \cellx8364\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Chirality/Stereochemistry\cell AB1234 is a single stereoisomer with the (2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 S}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 ) configuration.  \cell 
}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph107\trrh866\trleft-108\trftsWidth1\trftsWidthA3\trwWidthA50\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil 
\cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4404\clshdrawnil \cellx8364\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\pard\plain \ltrpar\s31\ql \li0\ri0\sa240\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f0\insrsid10500643 Description\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
A yellow crystalline solid.\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 pH and pKa\cell pKa of 2.37.\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Melting Point\cell Material melts at approximately 160}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
C with decomposition at temperatures above approximately 190}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C.\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trrh731\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl 
\clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Solubility \cell The solubility of AB1234  sodium salt in water at 20}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
{\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C is approximately 35 mg/mL. Aqueous solubility is unaffected by pH in the range 1-8.\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trrh731\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trrh1406\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl 
\clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Hygroscopicity\cell 
AB1234 is not considered to be hygroscopic. No increase in moisture content was seen following storage at 25}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 C/90% RH, for 2 weeks.\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph108\trrh1406\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt
\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\row \ltrrow}\trowd \lastrow \ltrrow
\ts11\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Crystal Form\cell There is only one known crystalline form of AB1234. \cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4068\clshdrawnil 
\cellx3960\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4454\clshdrawnil \cellx8414\row }\pard\plain \ltrpar
\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615321}2.1.S.2\tab Manufacture{\*\bkmkend _Toc534615321}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615322}2.1.S.2.1\tab Manufacturer(s){\*\bkmkend _Toc534615322}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The drug substance, AB1234, is manufactured in accordance with Good Manufacturing Practice at the following facility:
\par \ltrrow}\trowd \lastrow \ltrrow\ts11\trgaph107\trrh1316\trleft-107\trkeep\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx4410\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx8927\pard \ltrpar\ql \li0\ri0\widctlpar\intbl
\tx993\tx4536\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Company Name
\par Street address
\par Town
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Country}{\rtlch\fcs1 \af0 \ltrch\fcs0 \cf2\insrsid10500643 \cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 \cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \lastrow \ltrrow
\ts11\trgaph107\trrh1316\trleft-107\trkeep\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx4410
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx8927\row }\pard\plain \ltrpar
\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615323}2.1.S.2.2\tab Description of Manufacturing Process and Process Controls{\*\bkmkend _Toc534615323}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615324}{\*\bkmkstart _Toc27320519}Synthetic route{\*\bkmkend _Toc534615324}{\*\bkmkend _Toc27320519}
\par }\pard\plain \ltrpar\qj \li0\ri0\sl240\slmult0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 XYZ123 was condensed with XYZ456 using thionyl chloride.  The resulting intermediate PQR123 was not isolated and was subsequently re
acted with XYZ789 to form PQR 456. This was isolated by crystallisation and then dissolved in toluene. Hydrogenation in the presence of a palladium catalyst resulted in the crude drug substance which was purified by crystallisation from aqueous ethanol.

\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615325}A 
flow diagram for the synthesis of AB1234 is provided in Figure 1 including starting materials, intermediates, solvents and reagents (including catalysts) for each stage and indicating stereochemical information where appropriate. Where intermediates are n
ot isolated this is indicated by the use of square brackets.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320520}Synthetic route for batches used in nonclinical studies{\*\bkmkend _Toc534615325}{\*\bkmkend _Toc27320520}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Two batches of AB1234 (R1234/01/1 and R5678/01/1) have been used in key nonclinical studies.  These batches were manufactured according to the flow diagram provided in Figure\~
1 but aqueous industrial methylated spirits (IMS) was used as the crystallisation solvent instead of aqueous ethanol.  
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 \page Figure 1\tab Flow Diagram for the Synthesis of AB1234
\par The flow diagram would be presented.
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615326}\page 2.1.S.2.3\tab Control of Materials{\*\bkmkend _Toc534615326}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Development of the synthesis of the active ingredient is still at an early stage.  Appropriate specifications for the starting materials and intermediates are not yet available but will be established as more experience of the manufactur
ing process is obtained. }{\rtlch\fcs1 \af0 \ltrch\fcs0 \cgrid0\insrsid10500643  
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\cgrid0\insrsid10500643 
\par [It may be necessary to discuss the stereochemical control of starting materials where chiral compounds are involved.]
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615327}2.1.S.2.4\tab Controls of Critical Steps and Intermediates{\*\bkmkend _Toc534615327}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 No information yet available.
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615328}2.1.S.2.5\tab Process Validation and/or Evaluation{\*\bkmkend _Toc534615328}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 No information yet available.
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615329}2.1.S.2.6\tab Manufacturing Process Development{\*\bkmkend _Toc534615329}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 No information yet available.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615330}2.1.S.3\tab Characterisation{\*\bkmkend _Toc534615330}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615331}{\*\bkmkstart _Toc27320521}2.1.S.3.1\tab Elucidation of Structure and Other Characteristics{\*\bkmkend _Toc534615331}{\*\bkmkend _Toc27320521}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The route of synthesis presented in Figure 1 and the spectroscopic studies performed, (Figures\~2-6) are consistent with the assigned chemical structure.  
\par These data were generated using AB1234 batch R1234/01/1, which was manufactured according to the flow diagram in Figure 1, with the exception that it was recrystallised from aqueous IMS.
\par }\pard \ltrpar\ql \li0\ri0\keep\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 The elemental analysis results are in agreement with theoretical values.
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Table 1\tab Elemental Analysis of AB1234 (Batch R1234/01/1)
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth4949\clshdrawnil \cellx7521\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Molecular Formula\cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth4949\clshdrawnil \cellx7521\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 
\clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Element\cell % Theoretical\cell % Found\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\row \ltrrow}\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 C\cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl 
\clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil 
\cellx2572\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 H\cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil 
\cellx2572\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\row \ltrrow}\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 N\cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 
{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2680\clshdrawnil \cellx2572\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2463\clshdrawnil \cellx5035
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2486\clshdrawnil \cellx7521\row }\pard \ltrpar
\ql \li0\ri0\sb240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 The infrared spec
troscopic data are consistent with the chemical structure of AB1234 by assignment of band maxima to the functional groups of the molecule.  The IR spectrum is presented in Figure 2.
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 The signals from a proton nuclear magnetic resonance (}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\fs18\up8\insrsid10500643 1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 H-NMR) spectrum were assigned to the protons in the molecule.  The signals from a carbon nuclear magnetic resonance (}{\rtlch\fcs1 \af0 \ltrch\fcs0 \fs18\up8\insrsid10500643 13}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C\_NMR) spectrum were assigned to the carbons present in the molecule.  All spectra obtained were consistent with the structure of AB1234.  The }{\rtlch\fcs1 \af0 \ltrch\fcs0 \fs18\up8\insrsid10500643 1}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 H-NMR and }{\rtlch\fcs1 \af0 \ltrch\fcs0 \fs18\up8\insrsid10500643 13}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C\_NMR  spectra and their assignments are presented in Figures 3 and 4 respectively.
\par The electrospray mass spectrum, presented in Figure 5 indicates the spectrum is consistent with the proposed structure.  The assignment of ions is presented in Table 3.
\par In 0.1M hydrochloric acid AB123456G exhibits UV absorbance maxima at about 204\~nm, 228\~nm and 258 nm.  The UV spectrum is presented in Figure 6.
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Figure 2\tab Infrared Spectrum of a Mineral Oil Mull of AB1234 (Batch R1234/01/1)
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [The IR spectrum would be presented.]
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil \cellx2836\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrtbl 
\clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Peak Wavenumber (cm}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\up7\insrsid10500643 -1}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \b\f1\fs20\insrsid10500643 )\cell Peak Type\cell Assignment\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil \cellx2836\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\row \ltrrow}\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl 
\clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil \cellx2836\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil 
\cellx2836\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil 
\cellx2836\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\row \ltrrow}\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil 
\cellx2836\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\row \ltrrow}\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil \cellx2836\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil 
\cellx5104\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell \cell \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb
\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2944\clshdrawnil \cellx2836\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2268\clshdrawnil \cellx5104\clvertalt
\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2551\clshdrawnil \cellx7655\row }\pard\plain \ltrpar
\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Figure 3\tab 400 MHz }{\rtlch\fcs1 \af0 \ltrch\fcs0 \fs18\up8\insrsid10500643 1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 H-NMR Spectrum of AB1234 (Batch R1234/01/1) in 2% w/v DCl in D}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\sub\insrsid10500643 2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 O
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [The }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\v0\f0\fs22\cf1\super\insrsid10500643 1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 H-NMR spectrum and a table of assignments would be presented}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 .]
\par }\pard\plain \ltrpar\qc \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Figure 4\tab }{\rtlch\fcs1 \af0 \ltrch\fcs0 \fs18\up8\insrsid10500643 13}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C-NMR Spectrum of AB1234 (Batch R1234/01/1) in 2% w/v DCl in D}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\sub\insrsid10500643 2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 O
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [The }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\v0\f0\fs22\cf1\super\insrsid10500643 13}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 C-NMR spectrum and a table of assignments would be presented}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 .]
\par }\pard\plain \ltrpar\qc \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Figure 5\tab Electrospray Product Ion Mass Spectrum of AB1234 (Batch R1234/01/1)
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [The mass spectrum and a table of assignments would be presented}{\rtlch\fcs1 \af0 \ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 .]
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Figure 6\tab Ultraviolet Absorption Spectrum of AB1234 (Batch R1234/01/1) in 0.1 M HCl
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [The UV spectrum and a table of assignments would be presented.]
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615332}{\*\bkmkstart _Toc27320522}2.1.S.3.2\tab Impurities{\*\bkmkend _Toc534615332}{\*\bkmkend _Toc27320522}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320523}Potential impurities from the synthesis and degradation of AB1234{\*\bkmkend _Toc27320523}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Potential drug-related impurities in AB1234 are presented in Table 2.
\par Other potential impurities which may arise during synthesis are residual palladium catalyst and residual organic solvents (ethanol and toluene) which are controlled by the specification for AB1234. 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [The inclusion of a specific test for individual residual solvents may be necessary depending on the solvent(s) used and based on dosing considerations.] 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Table 2\tab Potential Process Impurities and Degradation Products
\par \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft0\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind108\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1620\clshdrawnil \cellx1620\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2340\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx6660\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1800\clshdrawnil \cellx8460\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Code Name\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Structural Formula\cell Notes\cell 
Typical Level Observed\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft0\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind108\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1620\clshdrawnil \cellx1620\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2340\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx6660\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1800\clshdrawnil \cellx8460\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell }\pard\plain \ltrpar
\s29\ql \li0\ri0\sa240\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\v0\f0\fs22\cf1\insrsid10500643 Starting material, reagent, intermediate, degradant, process impurity catalyst etc\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trgaph108\trleft0\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind108\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1620\clshdrawnil \cellx1620\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2340\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2700\clshdrawnil \cellx6660\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1800\clshdrawnil \cellx8460\row }\pard\plain \ltrpar
\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615334}{\*\bkmkstart _Toc27320524}2.1.S.4\tab Control of Drug Substance{\*\bkmkend _Toc534615334}{\*\bkmkend _Toc27320524}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615335}{\*\bkmkstart _Toc27320525}2.1.S.4.1\tab Specification{\*\bkmkend _Toc534615335}{\*\bkmkend _Toc27320525}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Batches of the active ingredient will comply with the following specification.
\par Batches will be released for clinical trial purposes only if the impurity profiles can be supported by available nonclinical data
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Table 3\tab Specification for AB123456G
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Test\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Acceptance Criteria\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\pard\plain \ltrpar
\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Description}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 Yellow crystalline solid\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Identification}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\pard\plain \ltrpar
\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \tab AB1234 by IR\cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 The spectrum of th
e sample is concordant with that of the AB1234 authentic material.\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 AB1234 content by HPLC}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643  (% w/w)\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Greater than 97\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl
\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 
Drug-related impurities content by HPLC}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643  (%\~area) \line \tab Any unqualified impurity\line \tab 
\par    Total impurities\cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \line \line Not greater than 0.5 }{\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\f0\insrsid10500643 (limit to be defined based on dosing considerations)\line }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Not greater than 3.0\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 
\trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil 
\cellx3821\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl
\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Residual palladium by ICP
\cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Not greater than 3ppm\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl
\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Loss of Drying}{\rtlch\fcs1 
\af0 \ltrch\fcs0 \f1\fs20\insrsid10500643  (% w/w)}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643  }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \tab \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Not greater than 0.5\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3929\clshdrawnil \cellx3821\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4288\clshdrawnil \cellx8109\row }\pard\plain \ltrpar
\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615336}{\*\bkmkstart _Toc27320526}2.1.S.4.2\tab Analytical Procedures{\*\bkmkend _Toc534615336}{\*\bkmkend _Toc27320526}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The methods used to control the drug substance are summarised below. In the course of ongoing development analytical methods will continue to be optimised and revised methods implemented and appropriately validated.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303868}{\*\bkmkstart _Toc27320527}Description of AB1234{\*\bkmkend _Toc500303868}{\*\bkmkend _Toc27320527}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 A sample of the drug substance is examined for physical form and colour.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303869}{\*\bkmkstart _Toc27320528}Identification of AB1234by IR{\*\bkmkend _Toc500303869}{\*\bkmkend _Toc27320528}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The infrared absorption spectrum of the drug substance is recorded in the range of 4000\~cm}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  to 400 cm}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 .  The spectrum of the sample is compared to the spectrum of an authentic sample to ensure that it is concordant.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303870}{\*\bkmkstart _Toc27320529}AB1234 Content by HPLC{\*\bkmkend _Toc500303870}{\*\bkmkend _Toc27320529}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The method for determination of AB1234 content is an isocratic reversed-phase HPLC method, using a 3.5 \'b5
m C18 column, or suitably validated alternative.  The mobile phase is a mixture of methanol and water, with UV detection at 280 nm.  
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303872}{\*\bkmkstart _Toc27320530}Drug-related Impurities Content of AB1234 by HPLC{\*\bkmkend _Toc500303872}{\*\bkmkend _Toc27320530}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The method for the determination of drug-related impurities content of AB1234 is a reversed-phase gradient HPLC method, using a 5 \'b5m C8 column, or suitably validated alternative.  The mobile phase is a mixture of methanol and 
water, with UV detection at 280 nm.  
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303873}{\*\bkmkstart _Toc27320531}Loss on Drying of{\*\bkmkend _Toc500303873} AB123456G{\*\bkmkend _Toc27320531}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Perform according to USP <731>, drying at an oven temperature of 100}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
C for 3 hours.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320532}Residual Palladium{\*\bkmkend _Toc27320532}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The method for the determination of residual palladium is an ICP method.
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615337}{\*\bkmkstart _Toc27320533}2.1.S.4.3.\tab Validation of Analytical Procedures{\*\bkmkend _Toc534615337}{\*\bkmkend _Toc27320533}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 Only brief details of the validation performed are required. There should be sufficient validation data in place to assure that the methods are suitable for use.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320534}AB1234 Content by HPLC{\*\bkmkend _Toc27320534}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Validation of the method has been carried out to demonstrate specificity, linearity and repeatability.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320535}Drug-related Impurities Content of AB1234 by HPLC{\*\bkmkend _Toc27320535}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Validation of the method has been carried out to demonstrate specificity, repeatability and the limit of detection for each significant drug-related impurity.
\par }\pard\plain \ltrpar\s6\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel5\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 [The LOD should be provided for significant drug-related impurities] 
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615338}{\*\bkmkstart _Toc27320536}2.1.S.4.4\tab Batch Analyses{\*\bkmkend _Toc534615338}{\*\bkmkend _Toc27320536}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Batch analysis data are presented in Table\~4 for one batch of AB1234 manufactured for clinical use using the synthetic route provided in Figure\~
1, and for two batches of AB1234 manufactured using aqueous IMS and used in the key nonclinical safety studies.  
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [In addition to reporting impurities content against the specification, further impurity data should be included in the batch analysis table to provided further details of the impurity profile of key batches.]

\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\i\insrsid10500643 \sect }\sectd \ltrsect\lndscpsxn\pgwsxn15840\pghsxn12240\marglsxn1253\margrsxn1267\margtsxn1800\margbsxn1800\psz9\linex0\headery547\footery533\endnhere\sectdefaultcl\sftnbj {\headerr \ltrpar \pard\plain \ltrpar\s41\ql \li0\ri0\widctlpar
\tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f1\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \tab }{
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \tab 
\par }\pard \ltrpar\s41\ql \li0\ri0\widctlpar\brdrb\brdrs\brdrw10\brsp20 \tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}{\footerr \ltrpar \pard\plain \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\pvpara\phmrg\posxr\posy0\wraparound\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f1\fs18\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\field{\*\fldinst {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 PAGE  }}{\fldrslt {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\lang1024\langfe1024\noproof\insrsid10500643 11}}}\sectd \ltrsect
\lndscpsxn\pgwsxn15840\pghsxn12240\marglsxn1253\margrsxn1267\margtsxn1800\margbsxn1800\linex0\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri360\widctlpar\tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin360\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Table 4\tab Batch Analysis Data for Batches of AB123456G
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \page Batch Number\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \cell R1234/01/1\cell R5678/01/1\cell F00445\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 
\trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\pard\plain \ltrpar
\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Size (kg)\cell \cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 1.15\cell 3.2\cell 5.4\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Place of Manufacture\cell \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Site specified\cell Site specified\cell Site specified\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Date of Manufacture\cell \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Jun 1999\cell Dec 2000\cell July 2001\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Use\cell \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Nonclinical\cell Non clinical\cell Clinical\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 
\trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth5820\clshdrawnil \cellx12433\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Test\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Acceptance Criteria\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth5820\clshdrawnil \cellx12433\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Description\cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Yellow crystalline solid\cell Yellow crystalline powder\cell Yellow crystalline powder \cell Yellow crystalline powder\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil 
\cellx3283\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\pard\plain \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 
\ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Identification \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell \cell \cell \cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt
\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 AB1234 by IR}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 The spectrum of the sample is concordant with that of the AB1234 authentic material.\cell Conforms\cell Conforms\cell Conforms\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt
\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\pard\plain \ltrpar
\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 AB1234 content by HPLC \line }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 (% w/w)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Greater than 97\cell }\pard \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tqdec\tx882\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.2}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tqdec\tx742\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 97.4}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tqdec\tx782\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.5
\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trhdr\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\pard\plain \ltrpar
\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Drug-related impurities content by HPLC,}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643  (% area) \line \tab AB2460\line \tab AB125689\line \tab AB112233\line \tab Any unqualified impurity\line \tab Total\cell 
}\pard \ltrpar\s36\qc \li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \line \line For information only\line For information only\line For information only
\line Not greater than 0.X\line Not greater than 3.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tqdec\tx702\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \line \line 0.14
\line 0.23\line 0.11\line 0.13\line 0.74\cell }\pard \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tqdec\tx652\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \line \line 0.51\line 0.46
\line 0.32\line 0.14\line 2.2\cell }\pard \ltrpar\s36\ql \li0\ri0\sb40\sa40\widctlpar\intbl\tqdec\tx692\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \line \line 0.11\line <0.05\line <0.05
\line <0.05\line 0.5\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrtbl \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sa60\widctlpar\intbl\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Residual Palladium by ICP\cell }\pard \ltrpar\s36\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Not greater than 3ppm\cell 
}\pard \ltrpar\s36\ql \li0\ri0\widctlpar\intbl\tqdec\tx702\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 1\cell }\pard \ltrpar\s36\ql \li0\ri0\widctlpar\intbl
\tqdec\tx652\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 1\cell }\pard \ltrpar\s36\ql \li0\ri0\widctlpar\intbl\tqdec\tx692\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 1\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sa60\widctlpar\intbl\tx201\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Loss of Drying }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 (% w/w)\tab \cell }\pard \ltrpar
\s36\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Not greater than 0.5\cell }\pard \ltrpar\s36\ql \li0\ri0\widctlpar\intbl
\tqdec\tx702\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 <0.1\cell }\pard \ltrpar\s36\ql \li0\ri0\widctlpar\intbl\tqdec\tx652\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 <0.1\cell }\pard \ltrpar\s36\ql \li0\ri0\widctlpar\intbl\tqdec\tx692\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 <0.1\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrtbl \cltxlrtb\clftsWidth3\clwWidth3391\clshdrawnil \cellx3283\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3330\clshdrawnil \cellx6613\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx8553\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx10493\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1940\clshdrawnil \cellx12433\row }\pard\plain \ltrpar
\s38\ql \fi-360\li360\ri0\widctlpar\tx360\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par }\pard \ltrpar\s38\ql \fi-360\li360\ri0\widctlpar\tx360\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \sect }\sectd \ltrsect
\marglsxn1800\margrsxn1800\margtsxn1267\psz9\linex0\headery547\footery533\endnhere\sectdefaultcl\sftnbj {\headerr \ltrpar \pard\plain \ltrpar\s41\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f1\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \tab }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \tab 
\par }\pard \ltrpar\s41\ql \li0\ri0\widctlpar\brdrb\brdrs\brdrw10\brsp20 \tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}{\footerr \ltrpar \pard\plain \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\pvpara\phmrg\posxr\posy0\wraparound\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f1\fs18\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\field{\*\fldinst {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 PAGE  }}{\fldrslt {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\lang1024\langfe1024\noproof\insrsid10500643 12}}}\sectd \ltrsect
\marglsxn1800\margrsxn1800\margtsxn1267\linex0\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri360\widctlpar\brdrt\brdrs\brdrw10\brsp20 \tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin360\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4230\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615339}2.1.S.5\tab \tab Reference Standards or Materials{\*\bkmkend _Toc534615339}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615340}{\*\bkmkstart _Toc27320537}Confirmation of what is used as an authentic sample should be included{\*\bkmkend _Toc27320537}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320538}2.1.S.6\tab Container Closure System{\*\bkmkend _Toc534615340}{\*\bkmkend _Toc27320538}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\cgrid0\insrsid10500643 AB1234 is stored in double low density polyethylene bags, sealed with plastic ties, and placed in polyethylene (HDPE) kegs.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\lang1033\langfe1033\langnp1033\insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615341}{\*\bkmkstart _Toc27320539}2.1.S.7\tab Stability{\*\bkmkend _Toc534615341}{\*\bkmkend _Toc27320539}
\par {\*\bkmkstart _Toc424548348}{\*\bkmkstart _Toc491854165}{\*\bkmkstart _Toc534615342}{\*\bkmkstart _Toc27320540}Decomposition Chemistry{\*\bkmkend _Toc424548348}{\*\bkmkend _Toc491854165}{\*\bkmkend _Toc534615342}{\*\bkmkend _Toc27320540}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [A brief summary of decomposition studies performed to date would be included.]
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\i0\insrsid10500643 Forced degradation studies of AB1234 were conducted on the solid state.
\par Solid samples of AB1234 (Batch R1234/01/1) were stored at 60}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i0\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i0\insrsid10500643 C/75%\~
RH for 6 weeks, at 80}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i0\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i0\insrsid10500643 
C (under nitrogen, air and oxygen headspaces) for 2 weeks, under fluorescent light (1490 ft. candles) for 8 days.  
\par The principal degradation product was LM1122. The solid state samples showed no significant changes in appearance, AB1234 content, drug-related impurities or physical form under any of the conditions studied.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc424548349}{\*\bkmkstart _Toc491854166}{\*\bkmkstart _Toc534615343}{\*\bkmkstart _Toc27320541}Stability Studies{\*\bkmkend _Toc424548349}{\*\bkmkend _Toc491854166}{\*\bkmkend _Toc534615343}
{\*\bkmkend _Toc27320541}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [Stability data available to date would be presented]. 
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc424548350}
A stability study is ongoing for one batch of AB1234 manufactured according to the synthetic process described in Section 2.1.S.2.2. and packed in individual sealed polyethylene bags, simulating routine storage of the dr
ug substance.  Data are available to date for AB1234 stored for up to 6 months at 30}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
C/60% RH or 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C/75% RH, for up to 3 months at 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C/75% RH Exposed (i.e. in an open polythene bag), up to 3 months at 50}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
{\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C or for 7 days in a light cabinet. Samples were t
ested at appropriate intervals for description, AB1234 content and drug-related impurities.{\*\bkmkstart _Toc491854167}{\*\bkmkstart _Toc534615344}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320542}Results and Conclusions{\*\bkmkend _Toc424548350}{\*\bkmkend _Toc491854167}{\*\bkmkend _Toc534615344}{\*\bkmkend _Toc27320542}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [Depending on the extent of data available, it may be possible to state a retest period. If this is not stated then assurance should be prov
ided on the steps taken to ensure the quality of the drug substance at time of manufacture of the investigational medicinal product]
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \v0\f0\fs22\cf1\insrsid10500643 Results to date are summarised in Table 5.  There is no evidence of any significant physical or chemical changes in AB1234 
at any of the storage conditions.  No significant changes were observed in appearance, AB1234 content or drug-related impurities under any of the storage conditions including light exposure, and all results comply with specification.  
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 AB1234 should be stored at temperatures not exceeding 30}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C.
\par It will be tested to its full specification prior to use in the manufacture of batches of drug product.\sect }\sectd \ltrsect
\lndscpsxn\pgwsxn15840\pghsxn12240\marglsxn1253\margrsxn1267\margtsxn1800\margbsxn1800\psz9\linex0\headery547\footery533\endnhere\sectdefaultcl\sftnbj {\headerr \ltrpar \pard\plain \ltrpar\s41\ql \li0\ri0\widctlpar\brdrb\brdrs\brdrw10\brsp20 
\tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f1\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}{\footerr \ltrpar \pard\plain \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\pvpara\phmrg\posxr\posy0\wraparound\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f1\fs18\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\field{\*\fldinst {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 PAGE  }}{\fldrslt {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\lang1024\langfe1024\noproof\insrsid10500643 13}}}\sectd \ltrsect
\lndscpsxn\pgwsxn15840\pghsxn12240\marglsxn1253\margrsxn1267\margtsxn1800\margbsxn1800\linex0\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri360\widctlpar\brdrt\brdrs\brdrw10\brsp20 \tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin360\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Table 5\tab Summary of Stability Data for AB1234 (Batch R1234/01/1)
\par \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil \cellx11340\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Storage Condition\cell Storage Time \cell Mean AB1234 Content by HPLC \cell Drug-related Impurities by HPLC (% area)\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl
\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb
\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt
\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar
\s36\qc \li0\ri0\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 (Months)}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 (% w/w)\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 LM1122\cell LM5566\cell Largest Other Impurity\cell Total\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Initial\cell 0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.14, 0.14\cell 0.23, 0.24\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl
\tx884\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.14, 0.13\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.74, 0.73\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 30}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/60% RH\cell 3\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.14\cell 0.20\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.13\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.65\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt
\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil 
\cellx9630\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell 6\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.1}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.13\cell 0.18\cell 
}\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.12\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.68\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil 
\cellx6210\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol"
 \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/75% RH\cell 3\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \f1\fs20\insrsid10500643 98.1\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.12\cell 0.15\cell 
}\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.11\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.57\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell 6\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.5\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.12\cell 0.10\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.11\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.59\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/75% RH Exposed\cell 1\line 3\cell 
}\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.1\line 99.1}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.17\line 0.13\cell 0.20\line 0.14
\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.13\line 0.10\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.77\line 0.57\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 50}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C\cell 1\line 3\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.9\line 98.6}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell 
}\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.17\line 0.13\cell 0.22\line 0.19\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.14\line 0.12\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.85\line 0.66\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl
\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb
\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row \ltrrow}\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Light cabinet\cell 7 days\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.9}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.15\cell 0.22\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.12\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.77\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl
\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb
\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx4500\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6210\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx7920\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx9630\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx11340\row }\pard\plain \ltrpar\s38\ql \li0\ri0\widctlpar\tx360\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \sect }\sectd \ltrsect\pgwsxn12242\pghsxn15842\psz1\linex0\headery544\footery533\endnhere\sectdefaultcl\sftnbj {\headerr \ltrpar \pard\plain \ltrpar
\s41\ql \li0\ri0\widctlpar\brdrb\brdrs\brdrw10\brsp20 \tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f1\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}{\footerr \ltrpar \pard\plain \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\pvpara\phmrg\posxr\posy0\wraparound\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f1\fs18\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\field{\*\fldinst {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 PAGE  }}{\fldrslt {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\lang1024\langfe1024\noproof\insrsid10500643 23}}}\sectd \ltrsect
\pgwsxn12242\pghsxn15842\linex0\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri360\widctlpar\brdrt\brdrs\brdrw10\brsp20 \tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin360\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615345}2.1.P\tab DRUG PRODUCT{\*\bkmkend _Toc534615345}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615346}{\*\bkmkstart _Toc27320543}2.1.P.1\tab Description and Composition of the DRUG Product{\*\bkmkend _Toc534615346}{\*\bkmkend _Toc27320543}
\par {\*\bkmkstart _Toc384632852}{\*\bkmkstart _Toc384632959}{\*\bkmkstart _Toc406991453}{\*\bkmkstart _Toc409929205}{\*\bkmkstart _Toc410030564}{\*\bkmkstart _Toc410030986}{\*\bkmkstart _Toc410104021}{\*\bkmkstart _Toc410545541}{\*\bkmkstart _Toc412878902}
{\*\bkmkstart _Toc412879450}{\*\bkmkstart _Toc412879606}{\*\bkmkstart _Toc413046246}{\*\bkmkstart _Toc424548310}{\*\bkmkstart _Toc491854126}{\*\bkmkstart _Toc534615347}{\*\bkmkstart _Toc27320544}Description{\*\bkmkend _Toc384632852}
{\*\bkmkend _Toc384632959}{\*\bkmkend _Toc406991453}{\*\bkmkend _Toc409929205}{\*\bkmkend _Toc410030564}{\*\bkmkend _Toc410030986}{\*\bkmkend _Toc410104021}{\*\bkmkend _Toc410545541}{\*\bkmkend _Toc412878902}{\*\bkmkend _Toc412879450}
{\*\bkmkend _Toc412879606}{\*\bkmkend _Toc413046246}{\*\bkmkend _Toc424548310}{\*\bkmkend _Toc491854126}{\*\bkmkend _Toc534615347}{\*\bkmkend _Toc27320544}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 AB1234 Capsules, are Size 0 hard gelatin capsule comprising a Swedish orange body and cap and containing 1, 2.5 or 5 mg of AB1234 (present as the sodium salt).
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc384632701}{\*\bkmkstart _Toc384632853}{\*\bkmkstart _Toc384632960}{\*\bkmkstart _Toc406991454}{\*\bkmkstart _Toc409929206}{\*\bkmkstart _Toc410030565}{\*\bkmkstart _Toc410030987}{\*\bkmkstart _Toc410104022}
{\*\bkmkstart _Toc410545542}{\*\bkmkstart _Toc412878903}{\*\bkmkstart _Toc412879451}{\*\bkmkstart _Toc412879607}{\*\bkmkstart _Toc413046247}{\*\bkmkstart _Toc424548311}{\*\bkmkstart _Toc491854127}{\*\bkmkstart _Toc534615348}{\*\bkmkstart _Toc27320545}
Composition{\*\bkmkend _Toc384632701}{\*\bkmkend _Toc384632853}{\*\bkmkend _Toc384632960}{\*\bkmkend _Toc406991454}{\*\bkmkend _Toc409929206}{\*\bkmkend _Toc410030565}{\*\bkmkend _Toc410030987}{\*\bkmkend _Toc410104022}{\*\bkmkend _Toc410545542}
{\*\bkmkend _Toc412878903}{\*\bkmkend _Toc412879451}{\*\bkmkend _Toc412879607}{\*\bkmkend _Toc413046247}{\*\bkmkend _Toc424548311}{\*\bkmkend _Toc491854127}{\*\bkmkend _Toc534615348}{\*\bkmkend _Toc27320545}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The complete statement of the components and quantitative composition of AB1234 Capsules is given below in Table 6.
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Ref536271199}Table {\*\bkmkend _Ref536271199}6\tab Composition of AB1234Capsules 
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Component\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Quantity \line (mg/capsule)\cell 
Function\cell Reference to \line Standard\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 
\trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt
\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 AB1234 sodium salt}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 1\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb40\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 1.2\cell 3\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 6\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Active\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \v\f1\fs20\insrsid10500643 HSE\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \v\f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Pregelatinized Starch }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs18\insrsid10500643 148.8\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 147\cell 144\cell 
}\pard \ltrpar\s36\qc \li0\ri0\sb120\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Diluent\cell PhEur\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Sodium Starch Glycolate }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 25\cell 25\cell 25\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Disintegrant\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 PhEur\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Magnesium stearate}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 5\cell 5\cell 5\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Lubricant\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 PhEur\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trrh240\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Total Fill Weight\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 180\cell 180\cell 180\cell -\cell -\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trrh240\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 Capsule, gelatin}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 1\cell 1\cell 1\cell Capsule Shell\cell Supplier\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trrh240\trleft-108\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx1978\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth695\clshdrawnil \cellx2673\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx3369\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth696\clshdrawnil \cellx4065\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2086\clshdrawnil \cellx6151\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2087\clshdrawnil \cellx8238\row {\*\bkmkstart _Toc534615349}{\pntext\pard\plain\ltrpar \s38 \rtlch\fcs1 \af0 \ltrch\fcs0 
\f43\fs18\lang2057\langfe1033\langnp2057\langfenp1033 \hich\af43\dbch\af0\loch\f43 1.\tab}}\pard\plain \ltrpar\s38\ql \fi-360\li648\ri0\widctlpar\jclisttab\tx648\wrapdefault{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pndec\pnstart1\pnindent360\pnsp120\pnhang 
{\pntxta .}}\aspalpha\aspnum\faauto\ls1\adjustright\rin0\lin648\itap0\pararsid10500643 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \fs18\insrsid10500643 
Equivalent to 1, 2,5 or 5 mg AB1234, The actual quantity of AB1234 used may be adjusted based on the purity of each batch of drug substance. 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320546}2.1.P.2\tab Pharmaceutical Development{\*\bkmkend _Toc534615349}{\*\bkmkend _Toc27320546}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [Due to the early phase of development there may be no information to include in this section. It may be neces
sary by exception if discussion of pharmaceutical development, choice of excipients etc is appropriate to aid understanding of a novel or complex formulation.] 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615361}2.1.P.3\tab Manufacture{\*\bkmkend _Toc534615361}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615362}{\*\bkmkstart _Toc27320547}2.1.P.3.1\tab Manufacturer(s){\*\bkmkend _Toc534615362}{\*\bkmkend _Toc27320547}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \i\v0\f0\fs22\cf1\insrsid10500643 [The site of manufacture only may be stated but sites of assembly would  be required to be included in the application form].
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The manufacture of AB1234 Capsules is conducted in accordance with Good Manufacturing Practice at the following facilities:
\par \ltrrow}\trowd \lastrow \ltrrow\ts11\trgaph107\trleft-107\trkeep\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx4410\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx8927\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Company Name
\par Street address
\par Town
\par Country }{\rtlch\fcs1 \af0 \ltrch\fcs0 \cf2\insrsid10500643 \cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph107\trleft-107\trkeep\trftsWidth1\trpaddl107\trpaddr107\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx4410\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4517\clshdrawnil \cellx8927\row }\pard \ltrpar
\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615363}2.P.3.2\tab Batch Formula{\*\bkmkend _Toc534615363}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 For simple dosage forms it may not be necessary to include this information  in the CTA at this stage of development. {\*\bkmkstart _Toc534615364}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320548}2.1.P.3.3\tab Description of Manufacturing Process and Process Controls{\*\bkmkend _Toc534615364}{\*\bkmkend _Toc27320548}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc387150724}{\*\bkmkstart _Toc389471671}{\*\bkmkstart _Toc389552109}{\*\bkmkstart _Toc389885237}{\*\bkmkstart _Toc389900564}{\*\bkmkstart _Toc390059390}{\*\bkmkstart _Toc390075554}{\*\bkmkstart _Toc390076846}
{\*\bkmkstart _Toc406991462}{\*\bkmkstart _Toc409929214}{\*\bkmkstart _Toc410030573}{\*\bkmkstart _Toc410030995}{\*\bkmkstart _Toc410104030}{\*\bkmkstart _Toc410545550}{\*\bkmkstart _Toc412878911}{\*\bkmkstart _Toc412879459}{\*\bkmkstart _Toc412879615}
{\*\bkmkstart _Toc413046255}{\*\bkmkstart _Toc424548319}A simple flow diagram or a brief, general description of 
the method of manufacturing procedure would be presented. Specific make or model or equipment, equipment trade names, operating conditions and in-process controls would not be specified.  
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc491854137}{\*\bkmkstart _Toc534615365}The flow diagram of the manufacturing process of AB1234 Capsules is given in Figure 7.
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Ref536329458}Figure {\*\bkmkend _Ref536329458}7\tab Flow Diagram of the Manufacturing Process of AB1234 Capsules 1, 2.5 and 5 mg 
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\pard\plain \ltrpar
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000000000000040000002d0106000a00000024030300d9059b05fa05dc051a069b05040000002d010400040000002d01020004000000f0010600080000002606
0f000600ffffffff010007000000fc020000ffffff000000040000002d010600040000002d010700040000002d010600090000001d062100f000f000fc030c03
9a0b040000002d010600040000002d01020004000000f0010600040000002d010400030000001e00070000001604df035c0f2a03d60b05000000020101000000
040000002d010500050000000902000000000500000014023b03d60b050000002e01010000002b000000320a3b03d60b1500040000000000d20f800748617264
2067656c6174696e2063617073756c6573653c002e001c002e0017002e002e0013002e00170013002e0017002a002e002e002a002e0013002e002a00050000002e0100000000050000001402027f64c505000000020101000000040000002701ffff040000002d010000030000000000}}}}}\sectd \ltrsect
\pgwsxn12242\pghsxn15842\psz1\linex0\headery544\footery533\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320549}In-process Controls{\*\bkmkend _Toc387150724}{\*\bkmkend _Toc389471671}{\*\bkmkend _Toc389552109}{\*\bkmkend _Toc389885237}{\*\bkmkend _Toc389900564}{\*\bkmkend _Toc390059390}
{\*\bkmkend _Toc390075554}{\*\bkmkend _Toc390076846}{\*\bkmkend _Toc406991462}{\*\bkmkend _Toc409929214}{\*\bkmkend _Toc410030573}{\*\bkmkend _Toc410030995}{\*\bkmkend _Toc410104030}{\*\bkmkend _Toc410545550}{\*\bkmkend _Toc412878911}
{\*\bkmkend _Toc412879459}{\*\bkmkend _Toc412879615}{\*\bkmkend _Toc413046255}{\*\bkmkend _Toc424548319}{\*\bkmkend _Toc491854137}{\*\bkmkend _Toc534615365}{\*\bkmkend _Toc27320549}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 [It would not be anticipated that in-process controls would be specified at this stage of develop
ment with the exception of those for parenteral products or where they are required to ensure final product quality i.e. fill weight for powder in bottle formulations. If the section is not completed it would be deleted.]
\par {\*\bkmkstart _Toc534615366}{\*\bkmkstart _Toc27320550}2.1.P.3.4\tab Controls of Critical Steps and Intermediates{\*\bkmkend _Toc534615366}{\*\bkmkend _Toc27320550}
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Information will not usually be required in early stage development but may be necessary for complex or novel products.]
\par }\pard\plain \ltrpar\s44\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615367}[With the exception of parenterals this section would not be not be presented. If the section is not completed it would be deleted.]
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320551}2.1.P.3.5\tab Process Validation and/or Evaluation{\*\bkmkend _Toc534615367}{\*\bkmkend _Toc27320551}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\i\insrsid10500643 [Information will not usually be required in early stage development but may be necessary where this impacts on the safety of the product.]
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615368}{\*\bkmkstart _Toc27320552}2.1.P.4\tab Control of Excipients{\*\bkmkend _Toc534615368}{\*\bkmkend _Toc27320552}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615369}{\*\bkmkstart _Toc27320553}{\*\bkmkstart _Toc27363734}2.1.P.4.1\tab Specifications{\*\bkmkend _Toc534615369}{\*\bkmkend _Toc27320553}{\*\bkmkend _Toc27363734}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 
A list of the excipients with associated specifications would be provided together with a statement outlining the routine quality control procedures applied.  Pharmacopoeial and non-pharmacopoeial excipients would be listed separately.
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The following excipients used in the manufacture of the finished product are required to comply with the specifications listed below.  
\par These excipients will be tested for compliance with specifications until such time as confidence is gained in respect of approved sup
pliers, when reduced testing may be implemented.  In such cases, receipt of a Certificate of Analysis from the supplier will be required which shows full compliance with specification.  Additionally, sufficient identity tests will be implemented to confir
m the identity of the material.
\par Pregelatinized starch, sodium starch glycolate and magnesium stearate comply with the requirements of the Ph.Eur. The gelatine capsules are non-pharmacopoeial but the gelatine complies with the requirements of the Ph. Eur. Th
e magnesium stearate is of vegetable origin.
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \f0\fs24\lang1033\langfe1033\cgrid0\langnp1033\insrsid10500643 
For proprietary mixtures, e.g. colour concentrates for tablet film coating, flavours and gelatin capsule shells, which are not included in a pharmacopoeia but are established pharmaceutical excipients, it is pro
posed that information is presented to indicate that the material meets the supplier\rquote 
s standards and information such as the name of the supplier, qualitative composition may be provided.  A brief description of the routine quality controls applied would also be included.
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \f0\fs24\insrsid10500643 {\*\bkmkstart _Toc534615370}2.P.4.2\tab Analytical Procedures{\*\bkmkend _Toc534615370}
\par At this stage in development it would not be proposed that this information is presented and the section would be deleted.
\par {\*\bkmkstart _Toc534615371}2.P.4.3\tab Validation of Analytical Procedures{\*\bkmkend _Toc534615371}
\par At this stage in development it would not be proposed that this information is presented and the section would be deleted.
\par {\*\bkmkstart _Toc534615372}2.P.4.4\tab Justification of Specifications{\*\bkmkend _Toc534615372}
\par At this stage in development it would not be proposed that this information is presented and the section would be deleted.
\par }\pard\plain \ltrpar\s2\ql \li0\ri0\sb240\sa60\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \ab\ai\af1\afs28\alang1025 \ltrch\fcs0 \b\i\f1\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af1 \ltrch\fcs0 \b0\f0\fs24\insrsid10500643 {\*\bkmkstart _Toc534615373}{\*\bkmkstart _Toc27320554}{\*\bkmkstart _Toc27363735}2.1.P.4.5\tab Excipients of Human or Animal Origin}{\rtlch\fcs1 \af1 \ltrch\fcs0 \fs22\insrsid10500643 
{\*\bkmkend _Toc534615373}{\*\bkmkend _Toc27320554}{\*\bkmkend _Toc27363735}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615374}{\*\bkmkstart _Toc27320555}{\*\bkmkstart _Toc27363736}The gelatine in the capsules is of bovine origin. An EDQM Certificate of Suitability (RO-CEP 2000-xxx Rev 00 dated aa.bb.cccc).{\*\bkmkend _Toc27320555}
{\*\bkmkend _Toc27363736}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320556}{\*\bkmkstart _Toc27363737}2.1.P.4.6\tab Novel Excipients{\*\bkmkend _Toc534615374}{\*\bkmkend _Toc27320556}{\*\bkmkend _Toc27363737}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 None involved.
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\cgrid0\insrsid10500643 
\par [For novel excipients further information to demonstrate the safety of the material would be provided. }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 If the section is not completed it would be deleted{\*\bkmkstart _Toc534615375}]
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320557}{\*\bkmkstart _Toc27363738}2.1.P.5\tab Control of DRUG Product{\*\bkmkend _Toc534615375}{\*\bkmkend _Toc27320557}{\*\bkmkend _Toc27363738}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615376}{\*\bkmkstart _Toc27320558}{\*\bkmkstart _Toc27363739}2.1.P.5.1\tab Specification(s){\*\bkmkend _Toc534615376}{\*\bkmkend _Toc27320558}{\*\bkmkend _Toc27363739}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 The table lists as an example the tests that would be registered in a Phase I CTA. Addition
al tests may be included as appropriate for a particular drug product e.g. content uniformity. Limits included are for example only and would be listed for the drug product as appropriate for a particular drug product. It should be noted that ICH requirem
ents would not necessarily be met at Phase I for low dose products being used for single dose/short-term administration.
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Clinical trial batches will meet the following specification at release.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 
\par {\*\bkmkstart _Toc6816339}Table 7\tab Regulatory Specification for AB1234 Capsules 1, 2.5 and 5 mg{\*\bkmkend _Toc6816339}
\par \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\insrsid10500643 Test\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Acceptance Criteria\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \trowd \ltrrow
\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil 
\cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrnone \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\pard\plain \ltrpar
\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 
Description\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
A white to off-white powder contained in a Size 0 hard gelatin capsule comprised of a Swedish orange body and cap \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrnone \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb
\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789
\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\insrsid10500643 Identification of AB1234}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrnone \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl
\tx426\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 by HPLC\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 The retention time of the principal peak in the sample chrom
atogram corresponds to that of the principal peak in the standard chromatogram\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrnone \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil 
\cellx8789\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\pard\plain \ltrpar
\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\tx567\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\insrsid10500643 AB1234 content \line }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 by HPLC\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 90.0 \endash  110.0% of label claim\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl\tx567\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Degradation products }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 by HPLC}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Report results\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil 
\cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb60\sa60\widctlpar\intbl
\tx567\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Dissolution (% AB1234 released)\cell 
}\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Complies with USP, \line Q = 75 at 45 minutes\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth3369\clshdrawnil \cellx3261\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth5528\clshdrawnil \cellx8789\row }\pard\plain \ltrpar
\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615377}{\*\bkmkstart _Toc27320559}{\*\bkmkstart _Toc27363740}2.1.P.5.2\tab Analytical Procedures{\*\bkmkend _Toc534615377}{\*\bkmkend _Toc27320559}{\*\bkmkend _Toc27363740}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 A brief description of the analytical methods employed would be presented.
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The methods used to control the drug substance are summarised below. In the course of ongoing development, analytical methods will continue to be optimised and revised methods implemented and appropriately validated.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303879}{\*\bkmkstart _Toc534615378}{\*\bkmkstart _Toc27320560}{\*\bkmkstart _Toc27363741}Description of AB1234 Capsules{\*\bkmkend _Toc500303879}{\*\bkmkend _Toc534615378}{\*\bkmkend _Toc27320560}
{\*\bkmkend _Toc27363741}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc27320561}{\*\bkmkstart _Toc27363742}The capsules are examined for conformance of colour and shape. The contents are tipped out and examined against a white background{\*\bkmkend _Toc27320561}{\*\bkmkend _Toc27363742}

\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303881}{\*\bkmkstart _Toc534615380}{\*\bkmkstart _Toc6816343}{\*\bkmkstart _Toc27320562}{\*\bkmkstart _Toc27363743}Identification and Content of AB1234 in AB1234 Capsules by HPLC{\*\bkmkend _Toc6816343}
{\*\bkmkend _Toc27320562}{\*\bkmkend _Toc27363743}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 This method uses a LiChrosphere 100 RP18, 5um, 250 x 4mm column equilibrated at 40\'b0C.  The eluent is a linear gradient starting with 70% water with 0.05% trifluoroacetic acid and 30% acetonitrile with 0.05% trifluoroaceti
c acid and changing to 30% water with 0.05%\~trifluoroacetic acid and 70% acetonitrile with 0.05% trifluoroacetic acid over 20\~
minutes.  Detection is by UV at a wavelength of 274 nm. This method is stability indicating and will detect any degradation products present.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc500303884}{\*\bkmkstart _Toc534615383}{\*\bkmkstart _Toc27320563}{\*\bkmkstart _Toc27363744}{\*\bkmkend _Toc500303881}{\*\bkmkend _Toc534615380}Dissolution of AB1234 Capsules{\*\bkmkend _Toc500303884}
{\*\bkmkend _Toc534615383}{\*\bkmkend _Toc27320563}{\*\bkmkend _Toc27363744}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The dissolution of AB1234 Capsules is determined using Apparatus II of the USP, with a dissolution medium of 900 mL of ammonium acetate buffer at pH 4.0 and a paddle speed of 50 rpm.  Detection is by UV absorbance at 262 nm.  
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320564}{\*\bkmkstart _Toc27363745}2.1.P.5.3.\tab Validation of Analytical Procedures{\*\bkmkend _Toc27320564}{\*\bkmkend _Toc27363745}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 At this early phase only brief details of the validation performed would be provided, but sufficient validation data would be in place to assure that the methods are suitable for use.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320565}{\*\bkmkstart _Toc27363746}Identification and Content of AB1234 in AB1234 Capsules by HPLC{\*\bkmkend _Toc27320565}{\*\bkmkend _Toc27363746}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The method has been validated for specificity, linearity and repeatability.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320566}{\*\bkmkstart _Toc27363747}Dissolution of AB1234 Capsules{\*\bkmkend _Toc27320566}{\*\bkmkend _Toc27363747}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 The method has been validated for specificity, linearity and repeatability.
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615385}{\*\bkmkstart _Toc27320567}{\*\bkmkstart _Toc27363748}2.1.P.5.4\tab Batch Analyses{\*\bkmkend _Toc534615385}{\*\bkmkend _Toc27320567}{\*\bkmkend _Toc27363748}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615386}{\*\bkmkstart _Ref6035438}
Batch details and batch analysis data are provided in Table 8 for one batch of each strength of AB1234 Capsules.  All batches were manufactured according to the details described in Section 2.1.P.5.1 and tested by the methods described in Section 2.1.
P.5.2. {\*\bkmkstart _Ref6035444}{\*\bkmkend _Ref6035438}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320568}{\*\bkmkstart _Toc27363749}2.1.P.5.5\tab Characterisation of Impurities{\*\bkmkend _Toc27320568}{\*\bkmkend _Toc27363749}
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Include any information available to date.]
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615387}[It would be proposed that this section is used by exception dependent on the product. Where it is needed, a brief textual summary would be included of the critic
al impurities specific to the formulation, based on safety considerations. If the section is not completed it would be deleted.]
\par {\*\bkmkstart _Toc27320569}{\*\bkmkstart _Toc27363750}2.1.P.5.6\tab Justification of Specification(s){\*\bkmkend _Toc534615387}{\*\bkmkend _Toc27320569}{\*\bkmkend _Toc27363750}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Batches will be released for clinical trial purposes only if the impurity profiles can be supported by available nonclinical data
\par 
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 It would be proposed that this section be used by exception dependent on the product. If the section is not completed it would be deleted.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Table {\*\bkmkend _Ref6035444}10\tab Batch Analysis Data for Batches of AB1234 Capsules, 1 mg 
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Number\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 1111\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Input Drug Substance Batch Number\line \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 F004495
\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Size (Units)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 252\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Date of Manufacture\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 May 2002\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Site of Manufacture\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Company Name, Town\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Use\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Clinical\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil 
\cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Test\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Acceptance Criteria\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\cf2\insrsid10500643 \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil 
\cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Description \cell 
}\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 A white to off-white powder contained in a size
 0 hard gelatin capsule comprised of a Swedish orange body and cap\cell Conforms\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 Identification\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
The retention time of the principal peak in the sample chromatogram corresponds to that of the principal peak in the standard chromatogram\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Conforms\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \fi-325\li325\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin325 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 AB123456 Content\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.9 to 1.1 mg per capsule\line (90.0 
\endash  110.0% of label claim)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 1.02 mg \line (102.0 % of label claim)\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 Degradation Products\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Report result\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Dissolution\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Complies with USP,\line Q = 75% at 45 minutes\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99 % at 45 minutes\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row }\pard\plain \ltrpar\s33\ql \fi-1440\li1440\ri0\sa240\keepn\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615389}{\*\bkmkstart _Toc534615388}{\*\bkmkend _Toc534615386}
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par \tab Batch Analysis Data for Batches of AB1234 Capsules, 2.5 mg 
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Number\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 2222\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Input Drug Substance Batch Number\line \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 F004495
\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Size (Units)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 290\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Date of Manufacture\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 May 2002\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Site of Manufacture\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Company Name, Town\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Use\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Clinical\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil 
\cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Test\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Acceptance Criteria\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\cf2\insrsid10500643 \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil 
\cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Description \cell 
}\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 A white to off
-white powder contained in a size 0 hard gelatin capsule comprised of a Swedish orange body and cap\cell Conforms\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Identification\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 The retention time of the principal peak in the sample chromatogram corresponds to that of the principal peak in the standard chromatogram\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Conforms\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \fi-325\li325\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin325 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 AB123456 Content\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 2.25 to 2.75 mg per capsule\line 
(90.0 \endash  110.0% of label claim)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 2.45 mg \line (98.0 % of label claim)\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 Degradation Products\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Report result\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Dissolution\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Complies with USP,\line Q = 75% at 45 minutes\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 97 % at 45 minutes\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par Batch Analysis Data for Batches of AB1234 Capsules, 5 mg 
\par \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Number\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 3333\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Input Drug Substance Batch Number\line \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 F004495
\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Batch Size (Units)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 220\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Date of Manufacture\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 May 2002\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Site of Manufacture\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Company Name, Town\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\f1\fs20\insrsid10500643 Use\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Clinical\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trkeep\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth6522\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil 
\cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Test\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Acceptance Criteria\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\cf2\insrsid10500643 \cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil 
\cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Description \cell 
}\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
A white to off-white powder contained in a size 0 hard gelatin capsule comprised of a Swedish orange body and cap\cell Conforms\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow
\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Identification\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 The retention time of the principal peak in the sample chromatogram corresponds to that of the principal peak in the standard chromatogram\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Conforms\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrtbl \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \fi-325\li325\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin325 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 AB123456 Content\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 4.5 to 5.5 mg per capsule\line (90.0 
\endash  110.0% of label claim)\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 5.1 mg \line (102.0 % of label claim)\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 
\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\pard\plain \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 Degradation Products\cell }\pard \ltrpar\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Report result\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row \ltrrow}\pard\plain \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tx325\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Dissolution\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Complies with USP,\line Q = 75% at 45 minutes\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98 % at 45 minutes\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth2112\clshdrawnil \cellx2004\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth4410\clshdrawnil \cellx6414\clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrs\brdrw10 
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2199\clshdrawnil \cellx8613\row }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 2.1.P.6\tab Reference Standards or Materials{\*\bkmkend _Toc534615388}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 [Due to the early phase of development it would not be proposed that any information on reference standards or materials would be presented and the section would be deleted.]
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320570}{\*\bkmkstart _Toc27363751}2.1.P.7\tab Container Closure System{\*\bkmkend _Toc534615389}{\*\bkmkend _Toc27320570}{\*\bkmkend _Toc27363751}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc534615390}The capsules are packaged into HDPE bottles, and closed with child-resistant plastic induction seal screw caps.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320571}{\*\bkmkstart _Toc27363752}2.1.P.8\tab Stability{\*\bkmkend _Toc534615390}{\*\bkmkend _Toc27320571}{\*\bkmkend _Toc27363752}
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 At Phase I it would be proposed that stability studies be conducted concurrently and tested at regular intervals thro
ughout the duration of the clinical trial. A shelf-life would be assigned on an ongoing basis as supported by stability data. A recommended storage statement would be stated.
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Stability studies are being conducted with testing for content, dissolution and d
egradation products at regular intervals to confirm the stability of AB1234 Capsules over the proposed study duration. Samples of the 1mg and 5mg capsules have been stored at 25}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL
 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 C/60%RH and at 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 C/75%RH for 6 weeks. The results are provided in Table 11. 
\par AB123456 Capsules will be stored at temperatures not exceeding 30}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
C with a shelf life of 6 months.
\par \sect }\sectd \ltrsect\lndscpsxn\pgwsxn15842\pghsxn12242\marglsxn1253\margrsxn1264\margtsxn1797\margbsxn1797\psz1\sbkcol\linex0\headery544\footery533\endnhere\sectdefaultcl\sftnbj \pard\plain \ltrpar
\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Table11\tab Summary of Stability Data for AB1234 Capsules 1mg 
\par \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Storage Condition\cell Storage Time \cell Mean AB1234 Content by HPLC \cell Dissolution
\par (% at  45 minutes)\cell Degradation Products by HPLC (% area)\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 (Weeks)}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell }{
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 (% w/w)\cell \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 LM1122
\cell LM5566\cell Largest Other Impurity\cell Total\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Initial\cell 0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 102.0}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.0\cell None detected\cell None detected \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\tx884\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 25}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/60% RH\cell 2\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 101.2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 97.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl
\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil 
\cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell 6\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.1}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 100.0\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.10\cell None detected\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.10\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil 
\cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/75% RH\cell 2\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.1\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.12\cell < 0.10\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.15\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \lastrow \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell 6\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.5\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 96.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.20
\cell 0.10\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.30\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par \sect }\sectd \ltrsect\pgwsxn12242\pghsxn15842\psz1\sbkodd\linex0\headery544\footery533\endnhere\sectdefaultcl\sftnbj {\headerr \ltrpar \pard\plain \ltrpar\s41\ql \li0\ri0\widctlpar
\tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f1\fs20\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \tab 
\par }\pard \ltrpar\s41\ql \li0\ri0\widctlpar\brdrb\brdrs\brdrw10\brsp20 \tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}{\footerr \ltrpar \pard\plain \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\pvpara\phmrg\posxr\posy0\wraparound\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f1\fs18\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\field{\*\fldinst {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 PAGE  }}{\fldrslt {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\lang1024\langfe1024\noproof\insrsid10500643 32}}}\sectd \ltrsect
\pgwsxn12242\pghsxn15842\linex0\endnhere\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri360\widctlpar\brdrt\brdrs\brdrw10\brsp20 \tqc\tx6480\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin360\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 
\par }\pard \ltrpar\s43\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cs42\insrsid10500643 \tab }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 \tab Summary of Stability Data for AB1234 Capsules 5mg 
\par \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 Storage Condition\cell Storage Time \cell Mean AB1234 Content by HPLC \cell Dissolution
\par (% at  45 minutes)\cell Degradation Products by HPLC (% area)\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 (Weeks)}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell }{
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 (% w/w)\cell \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\f1\fs20\insrsid10500643 LM1122
\cell LM5566\cell Largest Other Impurity\cell Total\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr
\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 Initial\cell 0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 102.0}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.0\cell None detected\cell None detected \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\tx884\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw15 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 25}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/60% RH\cell 2\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 103.0}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl
\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil 
\cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 \cell 6\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.1}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \f1\fs20\super\insrsid10500643 \cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 96.5\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.23\cell None detected\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.23\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil 
\cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\f1\fs20\insrsid10500643 40}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 {\field{\*\fldinst SYMBOL 176 \\f "Symbol" \\s 10}{\fldrslt\f3\fs20}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 C/75% RH\cell 2\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\widctlpar\intbl\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 99.1\cell }\pard \ltrpar
\s36\qc \li0\ri0\sb120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 98.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.19\cell  0.11\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\widctlpar\intbl
\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.30\cell }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 
\af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \trowd \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb
\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr
\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row \ltrrow}\trowd \lastrow \ltrrow
\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 \trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\pard\plain \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f43\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 \cell 6\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl
\tqdec\tx844\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 97.5\cell }\pard \ltrpar\s36\qc \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 92.0\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.25
\cell 0.15\cell }\pard \ltrpar\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx600\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 None detected\cell }\pard \ltrpar
\s36\ql \li0\ri0\sb120\sa120\widctlpar\intbl\tqdec\tx459\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 0.40\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \f1\fs20\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trgaph108\trleft-142\trkeep\trhdr\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind-34\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1582\clshdrawnil \cellx1440\clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1080\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1308\clshdrawnil \cellx3828\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1417\clshdrawnil \cellx5245\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx6955\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 
\cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx8665\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx10375\clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth1710\clshdrawnil \cellx12085\row }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 \sect }\sectd \ltrsect\pgwsxn11906\pghsxn16838\marglsxn1701\margrsxn1701\margtsxn1440\margbsxn1440\linex0\footery851\endnhere\sectdefaultcl\sftnbj \pard\plain \ltrpar
\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\fs24\insrsid10500643 {\*\bkmkstart _Toc534615395}2.1.A\tab APPENDICES{\*\bkmkend _Toc534615395}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615396}2.A.1\tab Facilities and Equipment{\*\bkmkend _Toc534615396}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Applicable to biotech products only and the section would be deleted.
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615397}{\*\bkmkstart _Toc27320572}{\*\bkmkstart _Toc27363753}2.1.A.2\tab Adventitious Agents Safety Evaluation{\*\bkmkend _Toc534615397}{\*\bkmkend _Toc27320572}{\*\bkmkend _Toc27363753}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 {\*\bkmkstart _Toc27320573}{\*\bkmkstart _Toc27363754}Gelatine used in the gelatine capsules has an EDQM Certificate of Suitability (RO-CEP 2000-xxx Rev 00 dated aa.bb.cccc).{\*\bkmkend _Toc27320573}{\*\bkmkend _Toc27363754}
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc534615398}[Information would be presented if appropriate. If the section is not completed it would be deleted.]
\par {\*\bkmkstart _Toc27320574}{\*\bkmkstart _Toc27363755}2.1.A.3\tab Novel Excipients{\*\bkmkend _Toc534615398}{\*\bkmkend _Toc27320574}{\*\bkmkend _Toc27363755}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 None involved.
\par }\pard\plain \ltrpar\s18\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 [Information would be presented if appropriate. If the section is not completed it would be deleted.]
\par {\*\bkmkstart _Toc534615399}{\*\bkmkstart _Toc27320575}{\*\bkmkstart _Toc27363756}2.1.A.4\tab Solvents for Reconstitution and Diluents{\*\bkmkend _Toc534615399}{\*\bkmkend _Toc27320575}{\*\bkmkend _Toc27363756}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 None involved.
\par }\pard\plain \ltrpar\s29\ql \li0\ri0\sa240\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \v\f1\fs20\cf6\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 It should be noted that this is not a CTD heading. Information would be presented for materials being supplied by the company if appropriate. If the section is not completed it would be deleted.
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 \page 
\par \ltrrow}\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl 
\cltxlrtb\clftsWidth3\clwWidth9000\clshdrawnil \cellx8892\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc465152844}PART III PHARMACO-TOXICOLOGICAL {\*\bkmkend _Toc465152844}DATA\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\fs28\insrsid10500643 
\trowd \lastrow \ltrrow\ts11\trqc\trgaph108\trleft-108\trftsWidth1\trpaddl108\trpaddr108\trpaddfl3\trpaddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrtbl \clbrdrl\brdrtbl \clbrdrb\brdrtbl \clbrdrr\brdrtbl \cltxlrtb\clftsWidth3\clwWidth9000\clshdrawnil 
\cellx8892\row }\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320576}{\*\bkmkstart _Toc27363757}INTRODUCTION{\*\bkmkend _Toc27320576}{\*\bkmkend _Toc27363757}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 This is a randomised, placebo controlled, study in approximately 20 healthy male volunteers.  AB 1234 reduces gastric acid secretion by inhibition of the gastric proton pump in the parietal cell. It is rapidly acting and animal data pr
ovides evidence of reversible control of gastric acid secretion with once daily dosing.
\par 
\par The batches of compound used in the toxicology studies had a similar impurity profile to those to be used in the proposed clinical trial.
\par }\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320577}{\*\bkmkstart _Toc27363758}
\par PHARMACOLOGY{\*\bkmkend _Toc27320577}{\*\bkmkend _Toc27363758}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320578}{\*\bkmkstart _Toc27363759}Summary{\*\bkmkend _Toc27320578}{\*\bkmkend _Toc27363759}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 AB1234 has been shown to be a selective proton pump inhibitor.  The proton pump inhibitory activity has been demonstrated in }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 in vitro}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
 functional studies and its acid reducing activity has been confirmed in a number of }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 in vivo}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  animal models.  No significant activi
ty has been demonstrated at 32 other receptor types investigated, with the exception that at high concentrations there was some evidence of }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 97 \\f "Symbol" \\s 11}{\fldrslt
\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \sub\insrsid10500643 1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  and }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 97 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \sub\insrsid10500643 2}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 -adrenoceptor binding activity.
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320579}{\*\bkmkstart _Toc27363760}Primary Pharmacodynamics{\*\bkmkend _Toc27320579}{\*\bkmkend _Toc27363760}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 AB1234 was shown to be 10 times more potent than omeprazole in the inhibition of pig H}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 +}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 /K}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\super\insrsid10500643 +}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 - ATPase with IC}{\rtlch\fcs1 \af0 \ltrch\fcs0 \sub\insrsid10500643 50}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  values of 2.0 x 10}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\super\insrsid10500643 -7}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 M and 2.6 x 10}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -6}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
M respectively. It showed approximately 5% of the activity of ouabain in inhibiting Na}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 +}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 /K}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 +}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 - ATPase. The IC}{\rtlch\fcs1 \af0 \ltrch\fcs0 \sub\insrsid10500643 50}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  value for the inhibition of stimulated acid secreti
on in isolated rabbit glands was 1.9 x 10}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -7}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 M. Reversibility of inhibition was observed in studies with pig gastric glands.
\par 
\par The acid secretion effect of single intraduodenal doses of 1,3,10 or 30 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  AB1234 on acid output, pepsin secretion and/or total
 volume were studied in rats with a ligated pylorus (Shay model) in which endogenous parasympathetic mediators stimulate acid secretion and in rats subjected to exogenous stimulation (subcutaneous injection of histamine). Acid output was inhibited to 10% 
of control values at the 30mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
 dose. The inhibition of acid secretion was a dose-dependent effect. No significant effect was seen on pepsin secretion or total volume.
\par 
\par In the dog chronic gastric fistula model with acid secretion stimulated by either histamine or pentagastrin, single and repeat daily intraduodenal doses inhibited acid secretion with an ED}{\rtlch\fcs1 \af0 \ltrch\fcs0 \sub\insrsid10500643 50}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  of 0.06 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 . 
\par 
\par In the \lquote Shay\rquote  model, no ulcers were seen in animals receiving AB1234 10mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 .
\par 
\par The effects of AB1234 on gastric acid secretion and histamine metabolism in the gastric mucosa in two strains of rat were examined. Urinary excretion of gastrin and histamine were increased following the administration of AB1234 10mg\'b7kg}{\rtlch\fcs1 
\af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 .
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320580}{\*\bkmkstart _Toc27363761}Secondary Pharmacodynamics{\*\bkmkend _Toc27320580}{\*\bkmkend _Toc27363761}
\par }\pard\plain \ltrpar\s6\ql \li0\ri0\sb240\sa60\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel5\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \insrsid10500643 [Include brief details, Do not include extensive information on study designs]
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\i\cf6\insrsid10500643 
\par }\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320581}{\*\bkmkstart _Toc27363762}SAFETY PHARMACOLOGY{\*\bkmkend _Toc27320581}{\*\bkmkend _Toc27363762}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320582}{\*\bkmkstart _Toc27363763}Summary{\*\bkmkend _Toc27320582}{\*\bkmkend _Toc27363763}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Safety Pharmacology studies were completed in accordance to the relevant ICH/CPMP Note for Guidance.  At high doses AB1234 produces transient hypotension, tachycardia, and slight increas
e in respiration following intravenous administration but not following oral dosing.  CNS effects were only seen at near lethal doses.  GI tract effects were those anticipated from the pharmacology of the product.
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \cf6\insrsid10500643 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Tabulated results helpful.  Extensive information on study design not needed.  Include details of all doses and routes used.  Provide justification if ICH/CPMP guidance document not followed.]
\par \ltrrow}\trowd \ltrrow\ts11\trgaph56\trrh335\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000{\*\bkmkstart _Toc27320583}{\pntext
\tab}\pard\plain \ltrpar\s4\qc \li0\ri0\sb120\sa240\keepn\widctlpar\intbl\jclisttab\tx360\tx1152\wrapdefault{\*\pn \pnlvlbody\ilvl3\ls152\pnrnot0\pndec\pnindent360\pnsp120 }\aspalpha\aspnum\faauto\ls152\ilvl3\outlinelevel3\adjustright\rin0\lin0 
\rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 \b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Test{\*\bkmkend _Toc27320583}\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Species\cell 
Dose\cell }\pard\plain \ltrpar\s2\ql \li0\ri0\sb240\sa60\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0 \rtlch\fcs1 \ab\ai\af1\afs28\alang1025 \ltrch\fcs0 
\b\i\f1\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af1 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320584}{\*\bkmkstart _Toc27363764}Results{\*\bkmkend _Toc27320584}{\*\bkmkend _Toc27363764}\cell }\pard\plain \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \trowd \ltrrow
\ts11\trgaph56\trrh335\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\row \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb
\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Gastrointestinal function\cell rat/mouse\cell 50 mg
\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  iv\cell }\pard \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 As expected from pharmacology\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt
\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \insrsid10500643 Respiratory function\cell dog\cell 10 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  iv\cell }\pard \ltrpar
\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Slight increase in respiration\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr
\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Renal function\cell dog\cell 10 mg\'b7
kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  iv\cell }\pard \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Transient decrease in blood flow\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt
\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \insrsid10500643 Cardiovascular system\cell Conscious dog\cell 10 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  iv\cell }\pard \ltrpar
\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Decreased blood pressure
\par Tachycardia\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 
\trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\row \ltrrow}\trowd \lastrow \ltrrow\ts11\trgaph56\trrh546\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv
\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Behaviour/CNS activity\cell mouse\cell 30 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 
\af0 \ltrch\fcs0 \insrsid10500643  iv
\par 100 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  iv\cell }\pard \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 No adverse findings
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Convulsions in 1/6 animals\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph56\trrh546\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb
\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx2520\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx3960\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1584\clshdrawnil \cellx5544\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth3456\clshdrawnil \cellx9000\row }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Include any data on Toxicokinetics to enable discussion of pharmacokinetics/ pharmacodynamic  relationships.]
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par }\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320585}{\*\bkmkstart _Toc27363765}PHARMACOKINETICS{\*\bkmkend _Toc27320585}{\*\bkmkend _Toc27363765}
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320586}{\*\bkmkstart _Toc27363766}Summary{\*\bkmkend _Toc27320586}{\*\bkmkend _Toc27363766}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Pharmacokinetic data were generated in the mouse, rat and dog . Kinetics would appear to be linear in all species at the doses tested. There were no apparent sex differences in the ADME profile of AB1234.
\par 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Avoid discussing species separately and instead discuss absorption, then distribution, metabolism and excretion.  If data generated as part of toxicology study (i.e. Toxicokinetic data) include here and not as separate section.]
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\i\cf6\insrsid10500643 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 AB1234 was rapidly absorbed following oral dosing (T}{\rtlch\fcs1 \af0 \ltrch\fcs0 \sub\insrsid10500643 max}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
 = 0.3-0.75 h) in all species studies (mouse, rat and dog).  Oral absolute bioavailability was 43% in the mouse and rat and 66% in the dog. 
\par 
\par The volume of distribution was high in all species, indicating that AB1234 is extensively distributed.  Whole body radiography studies in the rat indicate that the radiola
belled material was rapidly distributed to all organs with very limited CNS penetration.  Organs that showed the highest levels of radiolabelled material were the excretory organs and the adrenals.
\par 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 In vitro}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  studies in isolated hepatocytes from the differe
nt species indicate that there are two major metabolites (M1 and M2). There were no apparent qualitative differences between animals and man.  There was evidence of enzyme induction following repeat dosing with doses greater that 150 mg\'b7kg}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  in rats 
as evidenced by a smaller AUC value after 14 days treatment at this dose compared to Day 1.  }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 In vitro}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
 data to date would indicate that AB1234 is primarily metabolised by CYP3A4.
\par 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 In vivo}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  studies showed evidence of enzyme induction following repeat dosing with doses greater that 150 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
 in rats as evidenced by a smaller AUC value after 14 days treatment at this dose compared to Day 1. 
\par 
\par Excretion studies would indicate that AB1234 is excreted predominately in the urine of the mouse (90% of dose), b
ut urinary and faecal elimination were equally important in other species.  There was significant enterohepatic circulation of AB1234 in the rat.
\par 
\par No pharmacodynamic or kinetic drug interaction studies have been performed.
\par 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [A table like the following is extremely useful.  Inclusion of anticipated HUMAN plasma concentration believed to be required to produce meaningful clinical effect very helpful.]
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\i\cf6\insrsid10500643 
\par }\pard \ltrpar\ql \fi-1440\li1440\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Summary of kinetic data for AB1234 in animal species following oral administration.
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
\par \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1152\clshdrawnil \cellx1152\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1872\clshdrawnil \cellx3024\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx4158\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx5292\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1704\clshdrawnil \cellx6996\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth851\clshdrawnil \cellx7847\pard\plain \ltrpar\s4\ql \li0\ri0\sb120\sa240\keepn\widctlpar\intbl\tx1152\wrapdefault\aspalpha\aspnum\faauto\outlinelevel3\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 
\b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320587}Species{\*\bkmkend _Toc27320587}\cell }\pard\plain \ltrpar
\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Dose
\par (mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643  )\cell C}{\rtlch\fcs1 
\af0 \ltrch\fcs0 \b\sub\insrsid10500643 max}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643  (ng\'b7mL}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 )\cell T}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\sub\insrsid10500643 max}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643  
\par (hrs)\cell AUC}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\sub\insrsid10500643 (0-24)}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 
\par (ng.h/ml)\cell T}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\sub\insrsid10500643 1/2 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 (h)\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt
\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1152\clshdrawnil \cellx1152\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1872\clshdrawnil \cellx3024\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx4158\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx5292\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1704\clshdrawnil \cellx6996\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth851\clshdrawnil \cellx7847\row \ltrrow}\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Mouse\cell 100\cell }\pard \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 300\cell 0.3\cell 432\cell 0.5\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow
\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1152\clshdrawnil \cellx1152\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1872\clshdrawnil \cellx3024\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx4158\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx5292\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1704\clshdrawnil \cellx6996\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth851\clshdrawnil \cellx7847\row \ltrrow}\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Rat\cell 10
\par 75
\par 150\cell }\pard \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 30
\par 145
\par 460\cell 0.5
\par 0.5
\par 0.7\cell 152
\par 1100
\par 2300\cell 1
\par 1
\par 1.25\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb
\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1152\clshdrawnil \cellx1152\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1872\clshdrawnil \cellx3024\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx4158\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx5292\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1704\clshdrawnil \cellx6996\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth851\clshdrawnil \cellx7847\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Dog\cell 10
\par 30
\par 90\cell }\pard \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 40
\par 125
\par 350\cell 0.75
\par 0.75
\par 0.75\cell 201
\par 612
\par 1750\cell 4
\par 4
\par 4.2\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb
\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1152\clshdrawnil \cellx1152\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1872\clshdrawnil \cellx3024\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx4158\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1134\clshdrawnil \cellx5292\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1704\clshdrawnil \cellx6996\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth851\clshdrawnil \cellx7847\row }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 
\par 
\par 
\par 
\par 
\par 
\par 
\par }\pard\plain \ltrpar\s16\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\caps\f40\fs28\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 TOXICOLOGY
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320588}{\*\bkmkstart _Toc27363767}Summary{\*\bkmkend _Toc27320588}{\*\bkmkend _Toc27363767}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 All studies were
 performed in accordance with Good laboratory practice (GLP).  Repeat dose studies of up to 14 days duration were performed in the rat and dog as metabolic data indicate that these are relevant species.  The duration of the studies is sufficient to allow 
the proposed trial to commence.
\par 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Tabulated data is useful.  There is no need to provide extensive details of study designs.  Include details of ongoing studies].
\par \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\pard\plain \ltrpar\s4\ql \li0\ri0\sb120\sa240\keepn\widctlpar\intbl
\tx1152\wrapdefault\aspalpha\aspnum\faauto\outlinelevel3\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 \b\f1\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
{\*\bkmkstart _Toc27320589}Species{\*\bkmkend _Toc27320589}\cell }\pard\plain \ltrpar\qc \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Dose
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\fs20\insrsid10500643 (mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\fs20\super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\fs20\insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\fs20\super\insrsid10500643 -1}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \b\fs20\insrsid10500643  )}{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \cell Route\cell Duration\cell Findings\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 
\trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth9003\clshdrawnil \cellx9003\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Single Dose  Studies\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr
\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth9003\clshdrawnil \cellx9003\row \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Mouse\cell 200 \endash  2000\cell p.o.\cell 14 days observation.\cell Maximum non-lethal dose 800 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
, no specific target organ toxicity.\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 
\trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row \ltrrow
}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Rat\cell 200 \endash  2000\cell p.o.\cell 14 day obs.\cell Maximum non-lethal dose 850 mg\'b7kg}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 , no specific target organ toxicity.\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 
\trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth9003\clshdrawnil \cellx9003\pard\plain \ltrpar\s1\ql \li0\ri0\sb240\sa60\keepn\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0 \rtlch\fcs1 \ab\af1\afs32\alang1025 \ltrch\fcs0 
\b\f1\fs32\lang2057\langfe1033\kerning32\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af1 \ltrch\fcs0 \f0\fs24\insrsid10500643 {\*\bkmkstart _Toc27320590}{\*\bkmkstart _Toc27363768}Repeat dose studies{\*\bkmkend _Toc27320590}{\*\bkmkend _Toc27363768}\cell 
}\pard\plain \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth9003\clshdrawnil \cellx9003\row \ltrrow
}\trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Rat\cell 0, 20, 60, 150\cell p.o.\cell 14 days\cell 
Dose-related increase in plasma gastrin levels, Increase in stomach weights (}{\rtlch\fcs1 \af0 \ltrch\fcs0 \ul\insrsid10500643 >}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  60 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{
\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 ) with increased thickening of the mucosa. Similar effects have been seen with other \lquote 
azoles\rquote . Slight hepatocellular hypertrophy at 150 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 .\cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row \ltrrow
}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Dog\cell 0, 10, 30, 90\cell p.o.\cell 14 days\cell 
Dose-related increase in plasma gastrin levels, Increase in stomach weights (90 mg\'b7kg}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \'b7day}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1
}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 ) with increased thickening of the mucosa. Similar effects have been seen with other \lquote azoles\rquote .\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr
\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row \ltrrow}\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Rat\cell 0, 10, 50, 100\cell p.o.\cell 3 month\cell Ongoing
\par \cell }\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb
\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr
\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row \ltrrow}\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Dog\cell 0, 10, 30, 90\cell p.o.\cell 3 month\cell Ongoing\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr
\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth993\clshdrawnil \cellx993\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440\clshdrawnil \cellx2433\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth810\clshdrawnil \cellx3243\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1298\clshdrawnil \cellx4541\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4462\clshdrawnil \cellx9003\row }\pard \ltrpar
\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 
\par 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320591}{\*\bkmkstart _Toc27363769}Reproductive Toxicology{\*\bkmkend _Toc27320591}{\*\bkmkend _Toc27363769}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 No studies have been completed to date, preliminary teratology studies are ongoing.  Examination of testes and sperm parameters on rat repeated dose toxicity studies revealed no adverse effects.
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Mutagenicity and Genotoxicity
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\b\insrsid10500643 
\par \ltrrow}\trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx1980\clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1800\clshdrawnil \cellx3780\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth5220\clshdrawnil \cellx9000\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 Ames\cell 200 \endash  2500 }{\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 109 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 g\'b7plate}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1\cell }{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 Negative, }{\rtlch\fcs1 \af0 \ltrch\fcs0 \ul\insrsid10500643 +}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  S9 mix, evidence of toxicity at the top concentrations.\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr
\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx1980\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1800\clshdrawnil \cellx3780\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth5220\clshdrawnil \cellx9000\row \ltrrow}\pard \ltrpar\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \insrsid10500643 Human lymphocyte, CA test\cell 200 \endash  1750
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 {\field{\*\fldinst SYMBOL 109 \\f "Symbol" \\s 11}{\fldrslt\f3\fs22}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 g\'b7mL}{\rtlch\fcs1 \af0 \ltrch\fcs0 \super\insrsid10500643 -1\cell }{\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 Negative, }{\rtlch\fcs1 \af0 \ltrch\fcs0 \ul\insrsid10500643 +}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643  S9 mix, evidence of toxicity at the top concentrations.\cell }\pard \ltrpar
\ql \li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 \trowd \lastrow \ltrrow\ts11\trgaph56\trleft0\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr
\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trpaddl56\trpaddr56\trpaddfl3\trpaddfr3\tblind56\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth1980\clshdrawnil \cellx1980\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1800\clshdrawnil \cellx3780\clvertalt\clbrdrt\brdrs\brdrw10 
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth5220\clshdrawnil \cellx9000\row }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 
\par }\pard\plain \ltrpar\s17\ql \li0\ri0\sb120\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \b\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid10500643 {\*\bkmkstart _Toc27320592}{\*\bkmkstart _Toc27363770}
\par Discussion and Conclusion{\*\bkmkend _Toc27320592}{\*\bkmkend _Toc27363770}
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par The pharmacological profile of AB1234 is considered to support the proposed clinical trial(s). The pharmacokinetics are uncomplicated with the possible exception of enzyme induction at high doses.  This enzyme induction was probably respo
nsible for the hepatocellular hypertrophy and should not be problematic in man.  The only significant finding in the animal studies was a dose-related increase in plasma gastrin levels, which is an anticipated effect seen with proton pump inhibitors.  No 
other target organ toxicity was observed in rats and dogs respectively. 
\par 
\par }\pard\plain \ltrpar\s37\ql \li0\ri0\sa120\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 [Include any recommendations for specific monitoring to be used on proposed trials.  Include recommendations for maximum dose/plasma concentrations].
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par }\pard\plain \ltrpar\s6\ql \li0\ri0\sb240\sa60\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel5\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \i\f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 
\af0 \ltrch\fcs0 \insrsid10500643 [Tabulated summaries of pivotal studies (in the new Common Technical Document format) may be included as an appendix if it is believed these will be helpful to the reviewer/assessor.]  
\par }\pard\plain \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \f40\fs22\lang2057\langfe1033\cgrid\langnp2057\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid10500643 
\par 
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\ltrch\fcs0 \insrsid10500643 \page CLINICAL DATA
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\ltrch\fcs0 \insrsid10500643 Introduction
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\insrsid10500643 The proposed clinical trial is a single dose, open label, dose escalatio
n pharmacokinetic/ pharmacodynamic study in healthy male volunteers aged 18 to 45 years. The starting dose is x mg and this will be increased in steps of y mg according to a predetermined protocol.
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\ltrch\fcs0 \insrsid10500643 Study Design
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\insrsid10500643 The study design is an open label, ascending dose study with each dose administered to cohorts of 3 volunteers. 
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\ltrch\fcs0 \insrsid10500643 Starting dose and dose escalation
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\insrsid10500643 The starting dose will be x mg. This  has been based on the preclinical  pharmacokinetic data generated. A summary of the key data supporting the choice o
f starting dose has been provided in Table 1. The dosing increments used in the dose escalation will be y mg.
\par 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Table 1.
\par 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 [Provide a summary of the key data  supporting choice of dose and dosing increments}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 .]
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \i\insrsid10500643 
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\ltrch\fcs0 \insrsid10500643 Endpoints Studied
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\insrsid10500643 
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\insrsid10500643 [Provide a summary of the endpoints to be studied, including the timepoints for blood sampling for the PK/PD endpoints.]}{\rtlch\fcs1 \af0 \ltrch\fcs0 \i0\insrsid10500643  
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\ltrch\fcs0 \insrsid10500643 Safety Monitoring
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\b\insrsid10500643 
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\insrsid10500643 The safety monitoring to be undertaken is provided in Table 2. Since no safety signals were observed in the animal studies, this has been restricted to the standard battery of haematological and biochemistry parameters.
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\insrsid10500643 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \b\insrsid10500643 Table 2.
\par 
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\insrsid10500643 [Provide a flowchart listing the safety parameters to be measured along with the timepoints at which these are considered.]
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\insrsid10500643 
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\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid10500643 
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